MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT 2.9 W/ TAPERED NDLS; SPORTS MED IMPLANTS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	06/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an initial left total hip arthroplasty approximately 2 years ago.Subsequently, 6 months ago there was complaint of left hip atrophy, tenderness, pain, and crepitus with rom.The patient had an injection due to pain, and bursitis.
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 802603602, femoral head 12/14 taper 36 mm, lot # 3036185.Catalog #: 00625006530, bone screw self-tapping 6.5 mm dia., lot # j6842337.Catalog #: 00620005022, shell porous with cluster holes 50 mm o.D., lot # 64501423.Catalog #: 00625006520, bone screw self-tapping 6.5 mm dia, lot # j6884909.Catalog #: 00630505036, liner standard 3.5 mm offset 36 mm, lot # 64778735.Catalog #: 00771100700, femoral stem 12/14 neck, lot # 64641592.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed due to medical records which stated the patient had pain and received a left hip bursa injection.Even though the earlier x-rays which stated that the implants were well fixed and aligned properly, in the last x-ray the patient was noted to have mild to moderate degenerative changes of their mid and lower spine.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: JUGGERKNOT 2.9 W/ TAPERED NDLS
• Common Device Name: SPORTS MED IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15699114
• Report Number: 0001825034-2022-02446
• Device Sequence Number: 15509153
• Product Code: MBI
• UDI-Device Identifier: 00880304548091
• UDI-Public: (01)00880304548091(17)250325(10)0002318924
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2025
• Device Model Number: N/A
• Device Catalogue Number: 110005096
• Device Lot Number: 0002318924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 104 KG